Melatonin Supplementation Improves Pain, Sleep Quality, and Total Plasma Antioxidant Capacity in Women with Fibrocystic Breast Disease: A Randomized, Double-blind, Placebo-controlled Trial
Abstract
Objective: Fibrocystic breast disease (FBD) is a prevalent benign breast disorder primarily affecting women of reproductive age. Characterized by breast pain (mastalgia), cystic and solid breast lesions, and associated hormonal imbalances. Melatonin, a hormone produced by the pineal gland, exhibits potent antioxidant, anti-inflammatory, and has been shown to improve sleep quality and mental health in various clinical populations. These properties suggest that melatonin may be a promising therapeutic option for symptom management in women with FBD. Methods: This randomized, double-blind, placebo-controlled trial enrolled 66 women aged 18–40 years with FBD, diagnosed according to American Cancer Society guidelines, at Beheshti Clinic, Kashan University of Medical Sciences. Participants were randomized to receive either melatonin (6 mg/day; n = 33) or placebo (n = 33) for 12 weeks. Primary outcomes included breast pain severity and high-sensitivity C-reactive protein (hs-CRP), while secondary outcomes assessed sleep quality, depression, anxiety, and biomarkers of oxidative stress and inflammation, including total antioxidant capacity (TAC), malondialdehyde (MDA). Findings: After 12 weeks, melatonin supplementation resulted in a significant reduction in breast pain scores (P = 0.006) and improvement in sleep quality (P = 0.02) compared to placebo. Additionally, TAC was significantly increased in the melatonin group (P = 0.01). No significant differences were observed for…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 66 participants or records.
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